FDA-Device2026-07-29Class IIPROCESSING DEFECT
Penumbra System RED 68 Reperfusion Catheter recalled for fracture risk due to manufacturing defect
OTHERNationwide distribution
Penumbra RED 68 catheter recalled for fracture risk
Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.
- If you use or have access to affected RED 68 catheters, stop using them immediately.
- Contact Penumbra, Inc. for instructions on device return or replacement.
- Healthcare facilities should verify lot numbers against the affected list and quarantine any matching inventory.
Hazard
Due to manufacturing issues, reperfusion catheters may fractures
Sold states
Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
Affected count
N/A
Manufactured in
6262 Patterson Pass Rd Ste A, N/A, Livermore, CA, United States
Products
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2770-2026Don't want to check this manually?
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